First Line Therapy for High Risk Acute GVHD

Exclusion Criteria

• •1. recipients of second allogeneic stem cell transplant.
• •2. acute GVHD induced by donor lymphocyte infusion, interferon.
• •3. received first line aGVHD treatment before enrollment.
• •4. overlap GVHD syndrome.
• •5. pregnant or breast-feeding women.
• •6. absolute neutrophil count (ANC) \<0.5×10e9/L or platelet count (PLT) \< 20×10e9/L
• •7. Serum creatinine \> 2.0 mg/dL or creatinine clearance \< 40 mL/min measured or calculated by Cockroft-Gault equation.
• •8. uncontrolled infection
• •9. human immunodeficiency virus infection
• •10. active hepatitis b virus, hepatitis C virus infection and need antivirus treatment.
• •11. Subjects with evidence of relapsed primary disease, or subjects who have been treated for relapse after the allo-HSCT was performed, or graft rejection.
• •12. allergic history to Janus kinase inhibitors.
• •13. Severe organ dysfunction unrelated to underlying GVHD, including:
• •Cholestatic disorders or unresolved veno-occlusive disease of the liver (defined as persistent bilirubin abnormalities not attributable to GVHD and ongoing organ dysfunction).
• •Clinically significant or uncontrolled cardiac disease including unstable angina, acute myocardial infarction within 6 months from Day 1 of study drug administration, New York Heart Association Class III or IV congestive heart failure, circulatory collapse requiring vasopressor or inotropic support, or arrhythmia that requires therapy.
• •Clinically significant respiratory disease that requires mechanical ventilation support or 50% oxygen.
• •14. Received Janus kinase inhibitor therapy after allo-HSCT for any indication.
• •15. Any condition that would, in the investigator's judgment, interfere with full participation in the study, including administration of study drug and attending required study visits; pose a significant risk to the subject; or interfere with interpretation of study data.